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ocentra masterplan 3 1 ocentra brachy
Nucletron
Summary: The ocentra masterplan 3 1 ocentra brachy is a medical device used in brachytherapy, primarily for cancer treatment. It is utilized by oncologists and radiation therapists to deliver precise radiation doses.
FDA Clearance Information
Pathway
510K
Number
K081281 ↗
Decision Date
May 20, 2008
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The ocentra masterplan 3 1 ocentra brachy was cleared through the FDA 510(k) pathway on May 20, 2008. It is manufactured by Nucletron and classified as a Class 2 device under product code MUJ.
What It Is
The ocentra masterplan 3 1 ocentra brachy is a sophisticated brachytherapy device designed to deliver targeted radiation therapy. It allows for precise placement of radioactive sources within or near a tumor, minimizing exposure to surrounding healthy tissues. This device is integral in planning and executing brachytherapy treatments, ensuring accurate dose delivery.
Clinical Applications
This device is commonly used in oncology settings, particularly for treating cancers such as prostate, cervical, and breast cancer. Radiation oncologists and medical physicists use it in hospitals and specialized cancer treatment centers. It is suitable for patients requiring localized radiation therapy, providing a high dose to the tumor while sparing nearby healthy tissue.
Indications for Use
The FDA indications for this device focus on its use in brachytherapy, a form of internal radiation treatment. It is indicated for patients with cancers that can benefit from precise, localized radiation, such as certain gynecological, prostate, and breast cancers.
Practical Considerations
The device is compatible with various radioactive isotopes and applicators, allowing flexibility in treatment planning. Clinicians should be familiar with the specific software and hardware requirements for optimal use. Proper training in handling radioactive materials and device operation is essential for safety and efficacy.
Frequently Asked Questions
What is ocentra masterplan 3 1 ocentra brachy used for?
It is used for delivering precise radiation therapy in brachytherapy, primarily for cancer treatment.
What specialties typically use this device?
Radiation oncologists and medical physicists typically use this device in oncology settings.
What are the FDA-cleared indications?
The device is indicated for use in brachytherapy for treating cancers that benefit from localized radiation, such as prostate, cervical, and breast cancers.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.